MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5FX28CM PC TTN HD CATH WOSH; TITAN HEMODIALYSIS CATHETER

Model Number THD155628SE.

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was connected to dialysis machine when he suddenly felt warmth.When lifting the blanket, it turned out that the venous lumen had come loose from the catheter, causing a significant bleeding.Since it happened on the venous side, there was no alarm from the machine because it could just release the pressure.The nurse immediately pushed the catheter back together in response.Patient has received a one-time antibiotic gift to prevent infection.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The inspection process includes a pull test to ensure the luer connection to the extension tubing is secure.Without an evaluation of the device a root cause cannot be determined.The report indicated the catheter has been implanted for over 3 years with no reported problems.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 15.5FX28CM PC TTN HD CATH WOSH
• Type of Device: TITAN HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 12862908
• MDR Text Key: 281160150
• Report Number: 2518902-2021-00068
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908053746
• UDI-Public: 884908053746
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/02/2023
• Device Model Number: THD155628SE.
• Device Catalogue Number: THD155628SE.
• Device Lot Number: MKAL250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention